Ampule for freeze dried biological material maintained under partial vacuum conditions and method of obtaining said biological material from said ampule without contaminating the surrounding atmosphere



Aug. 5, 1969 c, BENDER ET AL 3,459,185

AMPULE FOR FREEZE DRIED BIOLOGICAL MATERIAL MAINTAINED UNDER PARTIALVACUUM CONDITIONS AND METHOD OF OBTAINING SAID BIOLOGICAL MATERIAL FROMSAID AMPULE WITHOUT CONTAMINATING THE SURROUNDING ATMOSPHERE Filed Jan.10, 1966 INVEN TOR. CHA 21.55 a, gamma MAR r/N amexwswv United StatesPatent US. Cl. 128-272 2 Claims ABSTRACT OF THE DISCLOSURE A heatsealable evacuated ampule having means to permit safe and controlledopening. A filter is retained between score means, the upper one beinglocated for controlled opening above the filter to permit the pressureto be equalized with the inrushing air being filtered. The lower scoremeans permits the filter to be removed and provides for access to thecontainer contents. A desiccant and/or means to indicate the presence ofmoisture may be supported on the filter.

This invention relates to an ampule for the reception of biologicalmaterial which is maintained under partial vacuum conditions. Theinvention also includes a method of utilizing the biological materialcontained within the ampule without the possibility of contaminating thesurrounding atmosphere.

It is conventional to preserve various types of biological material suchas vaccines, viruses, and the like by freezedrying such material andmaintaining it within an ampule or other container under partial vacuumconditions. So long as the material is freeze-dried, and so long asmoisture does not enter the container, the material is preserved almostindefinitely. However, if the container should be ruptured and thevacuum lost and moisture enter the container, the biological materialcontained therein is on longer preserved.

Furthermore, in this type of container, certain biological materials areutilized which are extremely toxic if breathed or otherwise ingested.For example, if Smallpox vaccine is contained Within the ampule, and thevaccine should contaminate the atmosphere and get into the eyes of theuser of the material, blindness may ensue.

In the conventional ampule there is no method provided wherein a usercan determine Whether or not vacuum conditions have been maintainedwithin the ampule or whether moisture has entered. Conventionally, inorder to obtain some type of check, the user of the ampule listens forthe hiss of atmospheric air entering the ampule. This is not always aproper indication of lack of contamination since moisture might bepresent in the ampule despite the fact that a vacuum is still present.

Furthermore, in the conventional type of ampule, the breaking thereofwill, in many cases cause the material contained therein to spurt out ofthe ampule and may contaminate the room in which the ampule is opened.The material may, for example, get into the eyes of the operator andcause blindness.

In order to avoid the objections set forth hereinabove to theconventional structure the instant ampule of this invention has beenconstructed. The invention also includes the novel method steps involvedherein preventing the user of freeze-dried material from becomingcontaminated therewith.

The above sets forth a brief description of the instant See inventionand some of the objects and advantages thereof. Other objects andadvantages of this invention will become obvious to the reader of thisspecification as the description proceeds.

The invention will now be described by reference to the accompanyingdrawings which represent the best mode known to the inventors ofcarrying out their invention.

FIG. 1 is a perspective view of an ampule made in accordance with thisinvention showing the manner in which the biological material isfreeze-dried.

FIG. 2 is a view similar to that of FIG. 1 but showing the stopper meansin closed position and the manner in which the ampule is sealed afterthe biological material is freeze-dried.

FIG. 3 is a perspective view showing the manner in which the sealedampule is first opened to avoid contamination of the material containedtherein.

FIG. 4 is a perspective view showing the second step of opening theampule to avoid Spurting of the contents into the air of the room andcontaminating it.

FIG. 5 is a sectional view taken along lines 5-5 of FIG. 2.

FIG. 6 is a sectional view taken along lines 66 of FIG. 2.

The invention will now be further described by reference to the specificform thereof shown in the accompanying drawings. In this connection,however, the reader is informed that the specific form of this inventionas set forth herein is for illustrative purposes and for purposes ofexample only. Various changes and modifications can obviously be madewithin the spirit and scope of this invention and would occur to thoseskilled in this art.

The ampule 11 of this invention is formed with a closed bottom 12 and aninitially open top 13. A stopper 16 is placed within top 13 and normallycontains a transverse groove 15. Initially stopper 16 is ajar withinmouth 13 so as to provide for freeze-drying of the contents thereof aswill be subsequently explained. The biological material to befreeze-dried 14 is placed within container 11 and lies adjacent bottom12. An inwardly constricted portion or neck 17 is provided withincontainer 11 intermediate bottom 12 and top 13. A porous plug or filtermeans 18 is retained within the ampule by portion 17. Adjacent porousplug 18 is desiccating material 19 which preferably containscolorimetric indicating material associated therewith.

A first breakable portion 20 (preferably consisting of an inwardlyscored circumferential line) is disposed upon an ampule on one side ofand substantially below the plug 18 and above material 14. A secondbreakable portion 21 (again preferably consisting of an inwardly scoredcircumferential line) is disposed on the opposite side of plug 18.

In the use of the ampule of this invention the sides thereof are fusedtogether below top 13 and the portion 22 discarded. A new fused portion23 is then provided which is formed therewithin by means of theimpingement of sealing jets 24.

With the foregoing specific description the operation of this inventionmay now be explained.

The ampule of this invention is initially prepared and material to befreeze-dried 14 placed therein adjacent the bottom thereof. The porousplug 18 is then placed within ampule 11 and is retained by constrictedportion 17. The desiccating material (which is preferably a molecularsieve consisting of a synthetic zeolite) is then placed above plug 18and may be impregnated with colorimetric humidity indicating materialsuch as cobalt chloride. The arnpule is now attached to conventionalfreeze-drying apparatus with stopper 16 ajar and the freeze-dryingprocess continued until material 14 is properly freeze-dried. At thatpoint stopper 16 is placed within mouth 13 of the ampule in closedposition so as to maintain a vacuum within the ampule. Sealing jets24-24 are then placed in impingement with ampule 11 as shown in FIG. 2and the ampule then sealed, discarding portion 22.

After storage of the material the operator looks at the ampule anddetermines whether or not the colorimetric indicating material stillindicates a lack of moisture. If cobalt chloride is used, for example,the material will either be blue or the ampule must be discarded. A pinkcoloration of the cobalt chloride indicates that humidity contaminationhas occurred. The desiccating material contained within the ampule alsotends to remove any residual moisture that may have been present withinthe ampule during the freeze-drying process.

Assuming that the colorimetric material still indicates a lack ofmoisture and therefore lack of contamination within the ampule theampule is then broken along line 21 and portion 25 discarded. Air willthen rush in to the ampule in the direction of the arrows shown in FIG.3 but, since plug material 18 is present between the point of opening ofthe ampule and biological material 14 there will not be any squirting ofthe biological material within the air but this material will becontained within the ampule by plug 18. After portion 25 is discardedthe ampule is then broken along line 20 and portion 26 discarded. Atthis point, since there no longer is any partial vacuum in the ampule,there can be no spurting of the biological material outside of theampule. As a result there can be no contamination. The portion 27 ofampule 11 is now utilized as a conventional container, water is added toreconstitute the material contained therein, and the material is usedconventionally.

The foregoing sets forth the manner in which the objects of thisinvention are achieved.

We claim:

1. A container being under a partial vacuum, said container being formedof heat fusable glass and comprising a hollow tubular body having aclosed bottom and upstanding walls terminating in a heat fusableclosable top, said top being closed off prior to heat sealing with asplit stopper, a holding means formed between said top and bottomportions within said container body, a filter means supported above saidholding means, a specimen disposed within said container below saidfilter means, and at least two score marks formed in said containerwalls on opposite sides of said filter means, said score marks beingaxially spaced from said filter means to permit controlled separationofsaid ampule initially along the score mark above said filter means tobreak the vacuum and controlled separation below said filter means togain access to said container.

2. A container as described in claim 1 wherein a desiccating materialand colorimetric humidity indicating material is disposed above saidfilter means.

References Cited UNITED STATES PATENTS 2,372,182 3/1945 Barr 215332,477,926 8/ 1949 Greaves 128-272 2,896,807 7/1959 Shaw 128-272 XFOREIGN PATENTS 1,017,067 9/1952 France. 323,394 12/1934 Italy.

80,904 7/ 1934 Sweden.

DALTON L. TRULUCK, Primary Examiner U.S. Cl. X.R. 21532

